NCPA, Coalition Back PDUFA Provisions to Address Drug Shortages

Alleviating drug shortages remains an important part of the prescription drug user fee bill before Congress, which is why NCPA and a number of other organizations representing clinicians, hospitals and patients sent a joint letter offering recommendations to Congressional leaders.

The letter to Chairman Tom Harkin (D-IA) and Ranking Member Michael B. Enzi (R-WY) of the Senate Health, Energy, Labor, and Pension Committee relates to drug shortage provisions within the Food and Drug Safety and Innovation Act of 2012 (sometimes referred to as reauthorization of the Prescription Drug User Fee Act or PDUFA). The letter communicated the groups’ support of many aspects of both the House and Senate versions of the bill.

The groups support the early notification requirements on drug manufacturers (included in both versions of the bill) and believe that these requirements are an essential component to help alleviate shortages. The letter urges conferees to ensure that drugs and biologics used to treat blood and other disorders are included within the early notification requirements, specifically, human plasma protein therapies and their recombinant analogs. The groups support the approach taken by the House to encourage reporting, whereby a failure to report by a manufacturer would trigger an automatic letter by the Food and Drug Administration (FDA) requesting an explanation of why it did not report to FDA – making the matter one of public record.

The groups also call for further collaboration between FDA and the Drug Enforcement Administration (DEA), to examine the impact of quotas on controlled drugs. The organizations support the House language that allows for more flexibility of controlled drug quotas in order to avoid shortages. They also support a provision in the Senate version of the bill that would require FDA to create a task force charged with developing a strategic plan for preventing and mitigating drug shortages. The task force would consult with external stakeholders, such as the groups signed on this letter, for input on interagency coordination, communication and decision making as it relates to drug shortages.

Finally, the letter supports efforts to allow for repackaging of non-controlled medications in short supply for use within the same health system. It endorses a technical correction that would enable both hospital and non-hospital providers (such as oncology clinics) with the same health system to have access to repackaged drugs in short supply.